The prior art discloses pharmaceutical powder and tablet formulations which contain analgesic plus antacid ingredients. Tablet formulations of this type, such as Alka Seltzer also include components which produce effervescence when the tablet is placed in water. The effervescence aids in disintegrating or breaking-up the tablet when it is placed in water, and thereby assists in enhancing the rate at which the therapeutic components of the tablet dissolve in water. When the components of the tablet have completely dissolved in water the user then ingests the aqueous solution of the antacid and/or analgesic components.
A common analgesic employed in tablets and powders of the type described above is acetylsalicylic acid, commonly known as aspirin. However, it has become well known that, in sensitive individuals, aspirin leads to gastrointestinal upset and other undesirable side-effects. Moreover, the use of aspirin in children suffering from certain viral infections has been associated with the onset of Reyes Syndrome.
Due to the potential undesirable side effects which have been associated with the use of aspirin, acetaminophen, an aspirin substitute, has become the analgesic of choice. However, acetaminophen possesses a very pungent bitter flavor. The undesirable flavor and after-taste of acetaminophen is particularly prominent when acetaminophen is ingested in an aqueous solution due to the prolonged and extensive contact with the taste receptors (i.e., taste buds) of the tongue that occurs when a liquid is ingested.
In view of the foregoing, it is an object of this invention to provide a effervescent powder composition, and a tablet prepared therefrom, which is aspirin-free and is pleasant tasting.
In addition, effervescent tablet and powder formulations, such as those described above, typically employ various sodium salts as essential ingredients of the powder or tablet. For example, an antacid compound commonly employed in effervescent antacids is sodium bicarbonate. However, the ingestion of large amounts of dietary sodium has been associated with the onset or exacerbation of hypertension in some sensitive individuals. Moreover, food stuffs containing sodium are often intentionally excluded from the diet of individuals suffering from hypertension and a variety of other diseases.
Furthermore, conventional antacid/analgesic tablet and powder formulations often contain sucrose (table sugar) as a sweetening agent. The pharmaceutically active ingredients typically employed in the foregoing formulations sometimes have an undesirable and unpalatable flavor and sucrose sugar is typically added to counter-act or mask this unpleasant taste. Sucrose, however, is known to cause tooth decay and also should be avoided by certain individuals for medical reasons (i.e., diabetics).
It is, therefore, a further object of this invention to provide a palatable and pleasant testing effervescent antacid, analgesic powder and tablet formulation which is both sodium-free and sucrose free.
Finally, shelf-stability is an important property of any commercially available effervescent tablet formulation. This is because tablets, after being formulated and packaged, may be stored for considerable lengths of time before being purchased and used by a consumer.
It is, therefore, yet another object of the invention to provide a shelf-stable effervescent antacid, analgesic tablet formuation. The tablets of this invention are shelf-stable for at least about 6 to about 24 months or more when packaged in conventional air-tight packaging.